About convatec
convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in advanced wound care, ostomy care, continence care, and infusion care. The company provides products and services in around 90 countries. Convatec’s revenues in 2024 were over $2 billion. The company is a constituent of the ftse 100 index (lse:ctec). For more information, please visit http://www.convatecgroup.com.
the role
the quality assurance engineer will have a key position to support production as the main leader, assuring compliance with regulations, standards, and the quality management system (qms) internal procedures on new projects, process improvements, validation and re-validations, risk management, and customer complaints investigations. This role includes maintaining quality indicators and internal deviations related to nonconforming material to ensure effective follow-up within the quality system.
responsibilities
* process control related
* assure process control is followed during product manufacturing. Monitor process output and organize activities to meet and maintain product quality standards.
* support the quality system by handling non-conformity activities, corrective and preventive actions.
* define a classification of all non-conformities based on risk.
* coordinate and lead investigations/root cause analysis with involved team members (maintenance, production, logistics, engineering, etc.).
* review, update and develop procedures, instructions, and quality specifications as needed.
* collect and review objective evidence to complete investigations and ensure effectiveness of actions established.
* follow up the qa role as required by nc procedure (originator, owner, quality reviewer, approver, etc.).
* monitor process kpis (ppms, ncs, etc.) and present trends to ncrb, taking action as needed.
* ensure actions are supported or referenced to the quality system.
* promote continuous improvement ideas to achieve quality system simplicity across processes.
* provide support in areas where experience and technical knowledge can be applied (production, microbiology, systems, etc.).
* perform internal process audits when required.
* maintain communication with other departments (mx/dk) regarding quality problems.
* create quality alerts and assist in defining quality criteria when needed.
* projects & validation related
* participate in development teams with responsibilities for quality and compliance with regulations or applicable standards.
* update and develop pfmeca from risk management related to project changes, internal inputs, etc.
* support risk assessment preparation when needed.
* support the development of verification and validation of products.
* establish and maintain a validation master plan (vmp) for re-validation of process equipment, including validation history and ensuring approval and communication to relevant areas.
* coordinate with production and engineering to ensure resource planning for re-validation activities.
* ensure validation documentation follows procedures and applicable regulations.
* review acute maintenance on process equipment for re-validation needs (per document 4705007).
* manage software validations in all systems in collaboration with project leader.
* collaborate on validation of molds and molding machines with quality engineering support.
* comply with the company quality policy.
* support iq/oq/pq validations of test equipment validation.
* safety, health, and environment (ehs) responsibilities
* comply with safety, health and environmental policy and ehsms procedures.
* maintain ehsms-related documentation up to date.
* participate in committees and training to ensure competency for the position where applicable.
* be aware of and support compliance with significant environmental aspects and impacts.
* understand ehs risk and legal requirements related to job responsibilities.
* execute duties with professional care and in compliance with legal requirements and internal standards, without compromising safety.
* identify and report ehs hazards and communicate with management as soon as identified.
* drive continuous performance improvement in ehs areas and recommend improvements.
* identify opportunities for improvement and implement actions to achieve desired results.
requirements
* verbal and written english, c1 level minimum
* cqe (certified quality engineer) by asq, a must
* experience in cost reduction projects, a must
* black belt certification
* bachelor’s degree (mechanical, electronic, industrial or similar)
* min. 3 years’ experience in engineering areas
* strong experience with quality management systems (qms)
* strong experience with quality control charts (histograms, pareto, process capability, control charts)
* strong experience with quality management tools (brainstorms, flow diagrams, cause-and-effect diagrams)
* continuous improvement mindset
* training/knowledge on fda qsrs and gmps, iso 13485, j-pal/ordinance no.169, eu and canadian medical devices regulations, or similar, preferred
* familiar with common computer software (ms office, etc.)
* availability to work in different shifts
* molding process knowledge
* able to travel if required
notice and equal opportunities
equal employment opportunities are provided for all current employees and applicants. This policy prohibits discrimination based on race, religion, creed, color, national origin, sex, age, marital status, disability, sexual orientation, gender identity, military or veteran status, genetic characteristics, or any other basis prohibited by law.
important notices
convatec is not accepting unsolicited resumes from agencies or search firms for this job posting. Resumes submitted without a valid written agreement are the property of convatec. No fee will be paid for unsolicited referrals. If you are an existing convatec employee, please use the internal career site to apply.
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